Apparatus and method to access the bone marrow for oncology and stem cell applications

ABSTRACT

An apparatus for removing portions of bone marrow from a bone is provided. The apparatus includes a housing and a hollow drive shaft operable to engage a gear assembly. The hollow drive shaft includes a first end operable to penetrate the bone and a second end operable to allow retrieval of portions of bone and bone marrow. The apparatus also includes a removable trocar. The removable trocar includes an inner channel operable to convey portions of bone and bone marrow. The gear assembly is able to engage and rotate the hollow drive shaft. A motor operable to drive the hollow drive shaft into the bone marrow by rotation of the hollow drive shaft and a power supply and associated circuitry operable to power the motor are also included.

RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.11/781,597 filed Jul. 23, 2007, which is a divisional of U.S. patentapplication Ser. No. 11/389,732 filed on Mar. 27, 2006, which is adivisional of U.S. patent application Ser. No. 10/448,650 filed May 30,2003, by Larry J. Miller, which claims priority to U.S. ProvisionalPatent Application Ser. No. 60/384,756 filed May 31, 2002. The contentsof these applications are incorporated herein in their entirety by thisreference.

TECHNICAL FIELD

The present invention is related to an apparatus and method forwithdrawing specimens from the bone or bone marrow. The apparatus andmethod can be used to extract stem cells or bone marrow fortransplantation or diagnostic purposes.

BACKGROUND OF THE INVENTION

There are many clinical conditions where it is important to be able toaccess and retrieve bone marrow. In some cases it may be necessary totreat diseases with a bone marrow or stem cell transplant to restorefunctioning blood cells in the body after high-dose chemotherapy. Suchconditions may include acute leukemias, brain tumors, breast cancer,Hodgkin's disease, multiple myeloma, neuroblastoma, non-Hodgkin'slymphomas, ovarian cancer, sarcoma and testicular cancer. In other casesit is necessary to access the bone marrow to obtain a sample of themarrow for diagnostic testing. These conditions may include cancer ofany type and hematologic disease of any origin.

Current techniques for gaining access to bone marrow can be difficult,traumatic and occasionally dangerous, depending on the site selected forharvest, the operator's expertise and the patient's anatomy. In general,the devices available for gaining access to the medullary cavity of thebone, where the bone marrow is located, include a trocar-fitted needle,with handles to facilitate application of pressure and rotation. Thesetypes of devices require substantial force to break through the outercortex of the bone by a fracturing technique. The exertion of highpressure upon the needle causes pain for the patient and often damagesthe tip of the needle. This is particularly a problem when harvestingfrom the sternum of a patient because the excess force can causepenetration through the sternum and can damage underlying structuressuch as the heart and great vessels.

Another disadvantage of current techniques to access the bone marrow isthat frequently more than one penetration site into the bone is requiredto retrieve enough bone marrow to either perform diagnostic tests or fortransplantation purposes. To retrieve an adequate sample of bone marrowfor either a bone marrow or stem cell transplant, a physician may needto put the needle into several different parts of the pelvis which mayrequire up to six needle puncture sites or more. This multiple-passrequirement can be extremely painful for a patient and may deter peoplefrom donating bone marrow. This technique of using multiple passes canalso cause fatigue in smaller operators who may lack strength tocomplete multiple-pass procedures.

Retrieving bone samples for diagnostic purposes is likewise difficult.Occasionally the core sample of bone is not retrieved because it is notextracted successfully with a standard biopsy needle. Thus, multipleattempts may be necessary to obtain a satisfactory bone or bone marrowbiopsy.

Current techniques require that biopsy needles be forced by manualpressure into bone. These techniques may have undesirable side effectssuch as damaging a needle tip or having the needle slide off theproposed bone target and into organs or soft tissues.

SUMMARY OF THE INVENTION

There is a need for an apparatus and method to access the bone marrowthat is minimally traumatic to the patient and that allows a sufficientamount of bone marrow to be removed the first time the bone ispenetrated. In accordance with teachings of the present invention, anapparatus and method for the removal of portions of bone marrow from abone are provided.

In one embodiment the apparatus includes a housing and a hollow driveshaft operable to engage a gear assembly. The hollow drive shaftincludes a first end operable to penetrate the bone and a second endoperable to allow retrieval of portions of bone and bone marrow. Thehollow drive shaft also includes an inner channel operable to conveyportions of bone and bone marrow. The apparatus also includes aremovable trocar with a first end operable to penetrate the bone and asecond end. The removable trocar includes an inner channel operable toconvey portions of bone and bone marrow. The gear assembly is able toengage and rotate the hollow drive shaft. A motor operable to engage thegear assembly and drive the hollow drive shaft into the bone marrow byrotation of the hollow drive shaft and a power supply and associatedcircuitry operable to power the motor are also included.

In another embodiment, an apparatus for removing portions of bone andbone marrow from a bone for diagnostic or therapeutic purposes isprovided that includes a housing and a hollow drive shaft operable toengage a gear assembly. The hollow drive shaft includes a first endoperable to attach to a penetrator and a second end operable to allowretrieval of portions of bone marrow. The hollow drive shaft alsoincludes an inner channel operable to convey portions of bone marrow toan operator. The detachable penetrator is able to penetrate the bonemarrow and collect specimens of bone marrow. Also included is a trocarhaving a first end operable to penetrate the bone marrow and a secondend. The trocar can be removably inserted into the inner channel of thehollow drive shaft. A connector operable to releasably attach thepenetrator to a hollow drive shaft is also included. A gear assemblyoperable to engage and rotate the hollow drive shaft is provided. Amotor operable to engage the reduction gear assembly and drive thepenetrator into the bone marrow by rotation of the hollow drive shaftand a power supply and associated circuitry operable to power the motorare also provided.

In a further embodiment of the invention a hollow drive shaft assemblyoperable to remove bone or tissue from a bone marrow is provided. Anouter hollow drive shaft and a removable inner trocar operable topenetrate the bone marrow are included. The outer hollow drive shaft isremovably coupled to a gear assembly and the outer hollow drive shaftincludes an inner channel operable to convey portions of bone and bonemarrow.

In a further embodiment of the invention a method for performing a bonemarrow biopsy is provided that includes inserting a hollow drive shaftand trocar into the bone marrow by means of a powered apparatus. Thetrocar may be removed from the hollow drive shaft and suction may beapplied to an inner channel of the hollow drive shaft so that portionsof bone and bone marrow may be retrieved from the inner channel of thehollow drive shaft.

An alternative method of performing a bone marrow biopsy is providedthat includes attaching a penetrator to a hollow drive shaft andinserting an inner trocar into the hollow drive shaft and penetrator.The penetrator is then inserted into the bone marrow by a poweredapparatus. The inner trocar is removed from the hollow drive shaft andpenetrator, and suction may be applied to the inner channel of thehollow drive shaft to retrieve portions of bone marrow. In a particularembodiment of the invention the site of bone marrow biopsy is controlledby a second end of the trocar comprising a ratcheted gear operable tocontrol the depth of sampling from the bone marrow.

In a further embodiment of the invention, a method of harvesting bonemarrow for transplantation is provided that includes inserting a hollowdrive shaft and inner trocar into the bone marrow by means of a poweredapparatus coupled with the hollow drive shaft. The inner trocar isremoved from the hollow drive shaft. A suction is then applied to theinner channel of the hollow drive shaft to retrieve portions of bonemarrow. The inner trocar may be replaced into the hollow drive shaft.The steps of removing the inner trocar from the hollow drive shaft andapplying suction to the inner channel of the hollow drive shaft toretrieve portions of bone marrow may be repeated until a sufficientquantity of bone marrow has been harvested for bone marrowtransplantation.

In a particular embodiment of the invention, the site of harvest withinthe bone marrow may be changed by a ratcheted gear attached to thesecond end of the trocar. The gear may be used to change the depth ofsampling from the bone marrow.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A illustrates an embodiment of an apparatus for removing a bonemarrow sample shown in longitudinal cross section.

FIG. 1B illustrates an embodiment of a hollow drive shaft of the currentinvention.

FIG. 1C illustrates an embodiment of a trocar of the current invention.

FIG. 1D illustrates an embodiment of an apparatus of the currentinvention.

FIG. 1E illustrates an embodiment of an apparatus for removing a bonemarrow sample shown in longitudinal cross section.

FIG. 2A illustrates an example of a hollow drive shaft or penetrator ofthe current invention.

FIG. 2B illustrates an example of a hollow drive shaft or penetrator ofthe current invention.

FIG. 2C illustrates an example of an inner trocar of the currentinvention.

FIG. 2D illustrates an example of a hollow drive shaft or penetrator ofthe current invention.

FIG. 3A illustrates an example of an attachment of the currentinvention.

FIG. 3B is an illustration of an attachment of the current invention.

FIG. 4A is an illustration of a hollow drive shaft and trocar of thecurrent invention.

FIG. 4B is an illustration of a hollow drive shaft and trocar of thecurrent invention.

FIG. 4C is an illustration of a hollow drive shaft and trocar of thecurrent invention in cross section.

FIG. 4D is an illustration of a hollow drive shaft and trocar of thecurrent invention in cross section.

FIG. 5A-C illustrates example gear assemblies of the current invention.

DETAILED DESCRIPTION OF THE INVENTION

Preferred embodiments of the invention and its advantages are bestunderstood by reference to FIGS. 1A-5C herein like numbers refer to sameand like parts.

FIG. 1A illustrates an example of an apparatus for removing bone marrowfrom a bone. Apparatus 10 may be used to obtain a sample of bone marrowfrom any suitable bone in the body such as the iliac crest or thesternum. In one embodiment, apparatus 10 includes housing 12, a hollowdrive shaft 14, removable trocar 19, gear assembly 37, motor 38 andpower supply 39. Housing 12 may include on/off switch 3, handle 5 andguard 6. Handle 5 may be angled downward to allow ease of operation andalso to allow end of hollow drive shaft 14 to turn without obstructionfrom a hand. Housing 12 encompasses power source 39, motor 38 andassociated circuitry 18, hollow drive shaft 14 and gear assembly 37.Hollow drive shaft 14 includes inner channel 15 and collar 16. Gear 17of gear assembly 37 engages collar 16 of hollow drill shaft 14 andthereby rotates hollow drive shaft 14.

Removable trocar 19 may be inserted into inner channel 15 of hollowdrive shaft 14. Trocar 19 is hollow and has an inner channel operable toconvey bone and bone marrow samples. Trocar 19 may have a handle 8 thatcan be used to tighten trocar 19 in place or to remove it from innerchannel 15 of hollow drive shaft 14. Hollow drive shaft 14 may includeluer lock connector 4 at the point where it exits housing 12. A luerlock connector may allow hollow drive shaft to connect to a suctionapparatus such as a tubing or syringe or to any other suitable apparatusthat would assist in obtaining a bone or bone marrow biopsy specimen. Anaccess port, such as a suction port may also releasably attach to an endof hollow drive shaft where it exits housing 12, for example to a luerlock connector. Such an attachment may be a plug, a port, a suctionapparatus, swivel port or other adapter.

FIG. 1B shows hollow drive shaft 14 removed from apparatus 10. In oneembodiment, hollow drive shaft 14 may include one or more thrustbearings 21. Thrust bearings may absorb pressure from the thrust of adrive shaft into bone during drilling. Also included in hollow driveshaft are side ports shown in further detail in FIG. 2. FIG. 1Cillustrates removable trocar 19 which includes handle 8. Handle 8 may beformed into a shape that is easily grasped and turned during the processof obtaining a biopsy. Removable trocar 19 may include one or more sideports operable to access a bone marrow specimen shown in greater detailin FIG. 2.

In one embodiment, shown in FIG. 1D, housing 12 may include a releasablehatch or door 12 a that may be opened to allow hollow drive shaft andattached gear 17 to be removed after use of apparatus 10. This may bedesirable where apparatus 10 is reusable and hollow drill shaft 14 andremovable trocar 19 are disposable. A releasable hatch or door may alsobe desirable to clean the inside of apparatus 10.

In another embodiment of the current invention, shown in FIG. 1E,detachable penetrator 20 may be attached to hollow drive shaft 14 bymeans of connector 36 and drilled into bone 2. In this embodiment,removable trocar 19 may be inserted into inner channel 15 of hollowdrive shaft 14 and into the hollow channel of penetrator 20. Penetrator20 may include side ports to permit access to bone and bone marrowsamples during a biopsy or bone marrow harvest procedure. One advantageof an embodiment that includes a detachable penetrator is it allowspenetrators of various sizes and configurations to be attached to hollowdrive shaft 14. In this embodiment, connector 36 includes an innerchannel operable to allow retrieval of bone and bone marrow specimens.

FIGS. 2A-D show an end 22 of either a hollow drive shaft or a penetratorthat is suitable to penetrate a bone. FIG. 2A, illustrates hollow driveshaft or penetrator end 22 which may include multiple sampling ports 23through which bone marrow or other biopsy material may be aspirated.Sampling ports 23 a, 23 b and 23 c are each operable to retrieve aportion of bone marrow. When removable trocar end 24 is in positionwithin inner channel of hollow drive shaft end 22 sampling port 13 ofremovable trocar end 24 may align with sampling port 23 a, 23 b, or 23c. An operator may determine the level in the bone marrow where aspecimen is taken or which sampling port (23 a, 23 b or 23 c) to alignwith trocar sampling port 13. Hollow drive shaft or penetrator end 22may include serrated tip 25 as shown in FIG. 2B or any other suitableconfiguration for sampling bone or bone marrow.

FIG. 2C shows removable trocar end 24 having a sampling port 13 near tip27 through which a sample of bone or bone marrow can be retrieved aswell as through a sampling port 23 a, 23 b or 23 c. When sampling port23 a, 23 b or 23 c of hollow drive shaft or penetrator 22 is alignedwith sampling port 13 of removable trocar 24, a portion of bone marrowmay be suctioned out of the bone. Removable trocar 24 may be removedallowing bone marrow to be suctioned through one or more sampling ports23 of hollow drive shaft or penetrator 22 at different sites in a bonemarrow cavity sequentially. FIG. 2D shows another example of tip 25 ofhollow drive shaft or penetrator end 22 having internal threads 26 thatare able to engage a specimen of bone and core it out as hollow driveshaft or penetrator 22 is drilled into bone. Threads 26 may engage andadhere to a portion of bone or to a semisolid substance such as bonemarrow and maintain contact with the specimen so it may be successfullyretrieved.

FIG. 3A shows operating mechanism 32 that may be included in someembodiments of the invention and may be attached to hollow drive shaft14 and manipulated to change the depth in a bone marrow where samplingoccurs. Operating mechanism 32 includes handle 35 and gear 33. Gear 33engages gear 34 attached to trocar 19. Suction port 28, shown attachedto trocar 19, may be used to retrieve portions of bone marrow from innerchannel 15 of hollow drive shaft 14.

FIG. 3B shows an example suction port 28 that may be connected to trocar19 where it exits housing 12. In one embodiment of the invention asuction port or suction swivel apparatus may also be connected to thehollow drive shaft 14. This feature allows a suction apparatus of thetype well known to one skilled in the art to be used to obtain bonemarrow samples. Suction port 28 may also be configured to attachdirectly to a penetrator for example in an embodiment of the inventionwhere the penetrator is detached from the housing before it is accessedfor bone marrow retrieval. Also shown in FIG. 3B is a suction swivelapparatus 45 that allows a suction tube 41 to attach to suction port 28.Suction swivel apparatus 45 allows suction port 28 to remain attached tosuction tube 41 while an attached drilling apparatus is drilling intobone marrow without kinking or twisting suction tube 41. Also shown inFIG. 3B is receptacle 43 that is interposed between suction tube 41 anda source of suction such that a bone marrow specimen may be successfullyretrieved into receptacle 43 and not lost into a suction machine.

FIG. 4A-D shows an example hollow drive shaft end or penetrator end 44and inner trocar 42 having a split-needle configuration. An inner trocar42 is inserted into a hollow drive shaft or penetrator end 44. Innertrocar 42 shown in the open position in FIG. 4A is advanced past the endof hollow drive shaft end or penetrator end 44 where it may be openedand inserted into bone, bone marrow or other tissue. Inner trocar 42 maybe closed, shown in FIG. 4B, so that a specimen is retained in its graspas it is withdrawn from the body. FIG. 4C shows a cross section of thesplit-needle inner trocar 42 where the tip of the inner trocar 42 is inthe open position. FIG. 4D shows a cross section of the trocar 42 isshown in the closed position.

The apparatus may or may not include a reduction gear assembly. Areduction gear assembly may include a worm gear assembly shown in moredetail in FIG. 5A and may include first connector 50 that connects shaft52 of motor 38 to worm gear 54. A reduction gear assembly may be used todecrease the RPMs between the motor and penetrator assembly to providean optimum RPM at the point of insertion of penetrator assembly intobone. FIG. 5B illustrates a further embodiment of a reduction gearassembly wherein a first spur gear 57 engages a second spur gear 58.FIG. 5C illustrates an alternate embodiment of a reduction gear assemblywherein spur gear 58 is offset forty-five degrees relative to hollowdrive shaft 14 which may be preferable in some embodiments of thepresent invention. In this embodiment spur gear 58 may be offset at anyangle and is not limited to forty-five degrees. Other gears may be usedin a reduction gear assembly, for example a planetary gear (notexpressly shown) may be used alone or in combination with a worm gear ora spur gear.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalternations can be made herein without departing from the spirit andscope of the invention as defined by the following claims.

1. A hollow drive shaft assembly operable to remove bone marrowspecimens from a bone for diagnostic or therapeutic purposes comprising:an outer hollow drive shaft operable to penetrate the bone andassociated bone marrow; the outer hollow drive shaft having an innerchannel operable to convey bone marrow specimens therethrough fordiagnostic or therapeutic purposes; the outer hollow drive shaft havingone end operable to penetrate the bone in response to rotation of thehollow drive shaft; and a removable trocar disposed within the outerhollow drive shaft with a first end of the removable trocar operable topenetrate the bone and associated bone marrow.
 2. The hollow drive shaftassembly of claim 1 wherein the first end of the removable trocarfurther comprises a tip with a cutting edge disposed thereon.
 3. Thehollow drive shaft assembly of claim 1 wherein the outer hollow driveshaft further comprises a body having at least one side port operable toobtain specimens of the associated bone marrow.
 4. The hollow driveshaft assembly of claim 1 wherein the removable trocar furthercomprises: an inner channel operable to convey bone marrow specimenstherethrough for diagnostic or therapeutic purposes; and at least oneside port operable to obtain specimens of the associated bone marrow. 5.The hollow drive shaft assembly of claim 1 wherein the one end of thehollow drive shaft further comprises serrated teeth operable topenetrate the bone and associated bone marrow.
 6. The hollow drive shaftassembly of claim 1 wherein the outer hollow drive shaft furthercomprises: internal threads disposed proximate the first end of theouter hollow drive shaft; and the internal threads operable to maintaincontact with a specimen of bone or bone marrow during retrieval.
 7. Ahollow drive shaft assembly operable to penetrate a bone and remove bonemarrow from the bone for transplantation purposes comprising: an outerhollow drive shaft having a first end operable to penetrate the bone andassociated bone marrow; the outer hollow drive shaft having a second endoperable to allow retrieval of bone marrow for transplantation purposes;a gear attached to the outer hollow drive shaft; the outer hollow driveshaft and attached gear operable to be disposed within a housing androtated by a motor disposed within the housing; the outer hollow driveshaft having an inner channel extending from the first end of the outerhollow drive shaft through the second end of the outer hollow driveshaft; the inner channel operable to convey bone marrow from the firstend of the outer hollow drive shaft through the second end of the outerhollow drive shaft for transplantation purposes after inserting thehollow drive shaft into the bone and associated bone marrow by the motorcoupled with the outer hollow drive shaft; a leur lock connectordisposed on the second end of the outer hollow drive shaft; and the leurlock connector operable to connect a suction apparatus to assist inobtaining bone marrow through the inner channel of the outer hollowdrive shaft; and the outer hollow drive shaft having sampling portsoperable to obtain portions of the associated bone marrow.
 8. The hollowdrive shaft assembly of claim 7 further comprising a removable trocarhaving a tip with a cutting edge. a removable trocar with at least onesampling port operable to obtain specimens of the bone marrow.
 9. Thehollow drive shaft assembly of claim 7 further comprising: a movabletrocar; an inner channel disposed within the removable trocar; and thesampling port of the removable trocar operable to be aligned with thesampling ports of the outer hollow drive shaft to retrieve a sample ofbone marrow.
 10. A hollow drive shaft and a trocar operable to penetratea bone and bone marrow comprising: a first gear attached to the hollowdrive shaft; the first gear operable to be engaged with a second gearattached to a motor to rotate the hollow drive shaft; the hollow driveshaft having a first end operable to penetrate the bone and associatedbone marrow; the hollow drive shaft having a second end operable toretrieve specimens of bone and the bone marrow; an inner channel formedin the hollow drive shaft; the inner channel of the hollow drive shaftoperable to convey specimens of bone and associated bone marrowtherethrough; a plurality of sampling ports formed in the hollow driveshaft spaced from the first end; the sampling ports operable to provideaccess to the associated bone marrow; the trocar operable to beremovably inserted the inner channel of the outer hollow drive shaft; asampling port formed in the trocar spaced from a first end of thetrocar; and the sampling port of the trocar operable to be aligned withrespective sampling ports of the outer hollow drive shaft to conveyportions of the bone marrow to an inner channel disposed within thetrocar.
 11. A hollow drive shaft operable to penetrate a bone and toremove a semisolid substance such as a bone marrow specimen from thebone comprising: an outer hollow drive shaft having a first end operableto penetrate the bone and associated bone marrow; the outer hollow driveshaft operable to be rotated by a motor; the outer hollow drive shafthaving a first end operable to penetrate the bone and associated bonemarrow; a threaded portion formed adjacent to the first end of the outerhollow drive shaft; and the threaded portion operable to retrieve a bonemarrow specimen.
 12. The hollow drive shaft assembly of claim 11 whereinthe first end further comprises serrated teeth.
 13. A hollow drive shaftassembly operable to remove bone or bone marrow from a bone fordiagnostic or therapeutic purposes comprising: an outer hollow driveshaft and a removable inner trocar operable to penetrate the bonemarrow; the outer hollow drive shaft removably coupled to a gearassembly; and the outer hollow drive shaft further comprising an innerchannel operable to convey portions of bone and bone marrowcharacterized by the removable trocar having an inner channel operableto convey portions of bone and bone marrow therethrough.
 14. The hollowdrive shaft assembly of claim 13 further comprising internal threadsoperable to engage a portion of bone or bone marrow.
 15. The hollowdrive shaft assembly of claim 13 wherein the hollow drive shaftcomprises a body with at least one side port operable to obtain portionsof bone marrow.
 16. The hollow drive shaft of claim 13 wherein the innertrocar comprises a tip with a cutting edge and further comprises a bodywith at least one side port operable to obtain bone marrow tissue fromthe bone marrow.
 17. A hollow drive shaft assembly operable to removebone or bone marrow from a bone for diagnostic or therapeutic purposescomprising: an outer hollow drive shaft and a removable inner trocaroperable to penetrate the bone marrow; the outer hollow drive shafthaving an inner channel operable to convey portions of bone or bonemarrow therethrough; the outer hollow drive shaft removably coupled to agear assembly; the outer hollow drive shaft further comprising an innerchannel operable to convey portions of bone or bone marrow; and aconnector operable to releasably attach a penetrator to the hollow driveshaft.
 18. The hollow drive shaft assembly of claim 18 wherein the innertrocar comprises a tip with a cutting edge and further comprises atleast one side port operable to obtain bone marrow tissue from the bonemarrow.